Novavax COVID-19 Vaccine Phase 1 Data Reaffirms Safety Profile and Ability to Elicit Immune Response

(Gaithersburg, MD, USA) has published Phase 1 data from its Phase 1/2 clinical trial of its COVID‑19 vaccine candidate, NVX-CoV2373, that shows the vaccine was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera.

NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease. NVX‑CoV2373 was created using Novavax’s recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains the company’s patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX‑CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection.

NVX-CoV2373 is currently in multiple Phase 2 clinical trials. The Phase 2 portion of the Phase 1/2 clinical trial to evaluate the safety and immunogenicity of NVX-CoV2373 began in August in the US and Australia, and expands on the age range of the Phase 1 portion by including older adults 60-84 years of age as approximately 50% of the trial population. Secondary objectives include preliminary evaluation of efficacy. In addition, a Phase 2b clinical trial to assess efficacy began in South Africa in August. The Phase 1 data from the Phase 1/2 clinical trial of NVX‑CoV2373 in healthy adults 18-59 years of age offered further detail on the previously announced results, in which NVX‑CoV2373 demonstrated a reassuring safety and reactogenicity profile and induced robust antibody responses numerically superior to that seen in human convalescent sera.

“The rapid publication of Phase 1 results from our trial in a prestigious peer-reviewed journal reflects both the importance of the data and the urgent need for an effective vaccine to slow the COVID-19 pandemic,” said Gregory M. Glenn, M.D., President of Research and Development at Novavax. “Based on the positive Phase 1 results, we have begun multiple Phase 2 clinical trials, from which we expect to collect preliminary efficacy. Novavax is committed to generating the safety, immunogenicity and efficacy data that will support confident usage of the vaccine, both in the US and globally, and the data published today further bolsters our conviction that this is possible.”

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